MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE REFLEX DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	805.88
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that an ophthalmic trocar could not be inserted into port before surgery.The surgery was completed after replacing the product with another one.The procedure type was unknown.The patient impact was not provided.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The instrument was received at the investigation site in the outer blister and the cover foil showing the lot information.The device was stuck at the blister with an adhesive tape.The product shows macroscopic signs of damage.Specifically, the grasping arms of the forceps are deformed.They are a few signs of surgery residues.The instrument was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirmed the macroscopically noticeable damage and displayed the deformation of the forceps arms in detail.The damage to the device does not correspond to the description in the report; it is not possible to perform further functional tests.Therefore, the point in time when the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause for the connection failure cannot be determined conclusively.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.No root cause for the customers reported event could be determined, since the situation that led to the instrument failure cannot be reconstructed.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.The complaint data will continue to be monitored for evidence of adverse trending and further action will be taken, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: FINESSE REFLEX DSP FORCEPS
• Common Device Name: FORCEPS, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22782622
• Report Number: 3003398873-2025-00349
• Device Sequence Number: 10046035
• Product Code: HNR
• UDI-Device Identifier: 07612717071711
• UDI-Public: (01)07612717071711(17)271231(11)250109(10)17754L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 805.88
• Device Lot Number: 17754L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown